Clinical Trials Listing
A complete listing of Brooks' active clinical trials for 2008 is compiled below. For more information on any study, please contact Jodi Morgan, Clinical Research Liaison, at (904) 306-8987, or Floris Singletary, Clinical Programs Coordinator, at (904) 306-8970.
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#612-2005: Electrical Stimulation for Dysphagia
Purpose: To compare traditional dysphagia therapy with and without electrical stimulation in a dysphagic population post CVA.
Study phase: Active enrollment through January 2009
Principal Investigator: Michael Crary, Ph.D. (352) 273-5299 or mcrary@phhp.ufl.edu
Enrollment Criteria: Participants must have pharyngeal dysphagia caused by a stroke, TBI, cancer or progressive neurogenic disorder. Must be three months post injury.
Electrical Stimulation flier 1
Electrical Stimulation flier 2
#435-2008 Psychosocial Factors Influence on Response to Falls Intervention program in older Adults
Purpose: The purpose of this study is to find out how individuals attitudes and thoughts, such as fear they might have about falling or pain, might affect the changes that they experience during intervention for a balance program.
Study Phase: Active Enrollment
Principal Investigator: Mark Bishop, PT, Ph.D. (352) 273-6112
Enrollment Criteria: Must be over 60 and had a history of two falls in the past year.
#152-2007: Urinary Levels of a Knee Osteoarthritis Biomarker During the Early Period after ACL Reconstruction
Purpose: To determine if urinary levels of CTX-II are elevated in the early period following ACL reconstruction. To examine the association of urinary levels of CTX-II with self report of function in the early period following ACL reconstruction.
Study Phase: Active enrollment through February 2009
Principal Investigator: Terese L. Chmielewski, Ph.D., PT, (352) 273-6104 or tchm@ufl.edu
Enrollment Criteria: Participants must be age 15-30 years old and receiving rehabilitation at Brooks Center for Sports Therapy. They cannot have had prior knee surgery and must agree to refrain from high-impact activities until after the T3 test session. Also looking for control subjects who are 15-30 years old who have had no lower extremity injury.
#07-173: Randomized Clinical Trials of Rehabilitation for Subacromial Impingement
Purpose: The purpose of this randomized clinical trial is to examine the short and long term effectiveness of a combination of manual therapy and therapeutic exercise as compared to therapeutic exercise only.
Study Phase: Active Enrollment
Principal Investigator: Chuck Thigpen, Ph.D., PT, ATC (904) 620-1431 or c.thigpen@unf.edu or Lori A. Michener, Ph.D., PT, ATC http://www.vcu.edu or (804) 828-0234
Enrollment Criteria: Participants must be between the ages of 14-80 with shoulder pain. They cannot have had previous shoulder surgery or rehabilitation for this pain.
Subacromial Impingement Trial Website
Subacromial Impingement Recruitment Flier
#HPD-ALL03310817Exp: The Effectiveness of a Standardized Program of Conditioning and Exercise Tolerance in Patients with Neck Pain: A Case Series
Purpose: The purpose of this project is to outline a standardized examination process and implement a evidence based treatment protocol for individuals with neck pain. This study will provide preliminary information and structure for a future proposed study to develop a clinical prediction rule to determine which patients with neck pain are likely to benefit from a program of conditioning and exercise tolerance.
Study Phase: Active enrollment in Brooks Waterford Lakes Outpatient Clinic
Principal Investigator: William Hanney, Brooks Rehabilitation PT, Ph.D. Student at Nova Southeastern University, (321) 615-6059 or hanney@nova.edu
Enrollment Criteria: Patients must be over the age of 18 and have a complaint of neck pain. They cannot have CNS involvement, signs of nerve compression, spasmodic torticollis, frequent migraines, fibromyalgia, prior surgery to the neck or thoracic spine or be pregnant.
# 582-2007 Immediate Effects on Sensation Perception Following Manual Therapy Interventions to the Thoracic spine
Purpose: The purpose of this study is to: 1. identify if there is an immediate local hypoanalgesic effect associated with a cervical region spinal manipulative therapy intervention in the upper-extremities 2. To identify if there is a difference in immediate local hypoanalgesic effects based on treatment (spinal manipulative therapy vs. specific exercises and 3. to identify if any psychological factors influence outcomes via self-report questionnaires.
Study Phase: Active Enrollment
Principal Investigator: Mark Bishop, PT, Ph.D., (352) 273-6112
Enrollment Criteria: Must be between 18-35 years of age and have no neck or upper-extremity complaints within the past sixty days.
#217-2007: Efficacy and Mechanism of Opioids for Chronic Low Back Pain: Central Sensitization for Opioid-Induced Hyperalgesia
Purpose: To investigate the efficacy and mechanisms of long term opioid use for chronic pain conditions. This specifically focuses on "central sensitization" as a potential mechanism for the phenomenon of opioid induced hyperalgesia.
Study phase: Data Analysis
Principal Investigators: Michael Robinson, Ph.D. (352) 273-6617 or merobin@ufl.edu and Virgil Wittmer, Ph.D. at (904) 858-7263 or Virgil.wittmer@brookshealth.org
#05-027: The Learning Trajectory for Patients with Spinal Cord Injury and the Teaching Trajectory for Spinal Cord Injury Nurses in a Rehabilitation Setting
Purpose: To investigate the best ways for a rehabilitation nurse to teach a patient with a SCI and how to facilitate learning.
Study phase: Active enrollment
Principal Investigator: Barbara Olinzoc, Ph.D., (904) 620-1467 or b.olinzoc@unf.edu
#313-2006: Restoring Walking in Non-Ambulatory Children with Severe Chronic Spinal Cord Injury ("Kids STEP")
Purpose: To determine if locomotor training can restore voluntary stepping in the absence of or with minimal voluntary movement in some individuals with severe chronic spinal cord injury.
Study phase: Active Enrollment
Prinicipal Investigator: Andrea Behrman, Ph.D., (352) 273-6117 or abehrman@phhp.ufl.edu
Enrollment Criteria: Children must be between the ages of three and ten years old and have experienced an incomplete spinal cord injury. They must have been previously ambulatory and now have very limited leg movement.
#131-2007: Developing a Computer Adaptive Measure of Functional Cognition for Stroke
Purpose: To develop a computer adaptive way to measure cognitive skills of acute and chronic stroke patients.
Study phase: Data Analysis
Principal Investigator: Craig Velozo, Ph.D., (352) 273-6128 or cvelozo@phhp.ufl.edu
Enrollment Criteria: Participants must have had a stroke within the past 12 months. Must have a caregiver or friend to participate with them.
#2007-044 Late Development of Epileptiform Activity on Electroencephalography in Cerebral Cortical Infarction
Purpose: The purpose of this study is to identify the percentage of patients with a history of stroke who later develop changes on an electroencephalogram (EEG), a study that records brain waves, which could be a risk for developing seizures.
Study Phase: Active Enrollment
Principal Investigator: Nader Antonios, M.D. (904) 244-9514
Enrollment Criteria: Participants must have had a stroke between 6months and 5 years ago.
#262-2005: Locomotor Experience Applied Post Stroke ("LEAPS")
Purpose: To compare two different treatment interventions to improve walking after stroke.
Study phase: Active enrollment through April 2009
Principal Investigator: Pam Duncan, Ph.D., (919) 286-3399 ext. 239
Enrollment Criteria: Participants must be screened within 45 days of stroke onset. They may be screened at Brooks Rehabilitation Hospital, referred by clinicians within the community or self referred.
LEAPS Methodology Published Article
#H501-2006: Matching the Needs of Stroke Patients with Caregiving Resources to Improve Outcomes
Purpose: To develop a decision making tool to target potential issues prior to patient discharge from facility.
Study phase: Data Analysis
Principal Investigator: Barbara Lutz, RN, Ph.D., (352) 273-6350 or bjlutz@nursing.ufl.edu
Enrollment Criteria: Patient must have had an inpatient rehabilitation stay at Brooks Rehabilitation Hospital. There also must be a caregiver involved.
#472-2001: Treating Intention in Aphasia: Neuroplastic Substrates
Purpose: To develop a treatment for increasing language function in nonfluent aphasics.
Study phase: Active enrollment through March 2009
Principal Investigator: Bruce Crosson, Ph.D., (352) 376-1611 ext 5329 or Local Contact: Cecila Brooks (904) 858-7260
Enrollment Criteria: Participants must be greater than 6 months post onset of stroke and have difficulty communicating. Must have been right handed prior to stroke and cannot have a history of seizures.
#06-00551300: The Brain Hemorrhage Cognitive Recovery Study
Purpose: To establish a natural history of cognitive recovery in survivors of spontaneous and warfarin-associated ICH (intracerebral Hemorrhage) and compare the cognitive recovery to that observed in ischemic subtypes of stroke.
Study phase: Active enrollment through May 2009
Co-Principal Investigators: Thomas Brott, M.D., Trevor Paris, M.D., and Beth Rush Ph.D., (904) 953-7286 or brott.thomas@mayo.edu
Enrollment Criteria: Participants must have experienced an ischemic stroke or intracerebral hemorrhage and were admitted to Brooks Rehabilitation Hospital within the first 3 weeks post onset. Also looking for volunteers from the community who are "stroke free."
Brain Hemorrhage Cognitive Recovery Study Brochure
#2005-054: Insulin Resistance Intervention after Stroke (IRIS) Trial
Purpose: To see if a new treatment (Pioglitazone) will prevent future strokes and heart attacks among persons with a recent stroke or transient ischemic attack (TIA)
Study phase: Active enrollment through December 2009
Principal Investigator: Scott Silliman, M.D. (904) 244-9945 or Scott.silliman@jax.ufl.edu
Enrollment Criteria: Participants must have had an stroke or TIA within the past 180 days. Cannot be diabetic or taking any insulin related medications.
#335-2007: Translating Motor Learning and Neural Plasticity Principles to Stroke Care at Brooks Rehabilitation Hospital: From Efficacy to Effectiveness
Purpose: To translate principles of neural plasticity and motor learning into the stroke program of care at Brooks Rehabilitation Hospital. Practice is the known strongest variable for motor learning to occur and task-related practice is advocated during stroke rehabilitation to improve functional performance of daily activities. Concordant studies of neural plasticity indicate that repetition of a newly learned (or relearned) movement sequence is required to induce lasting neural changes.
Study phase: Data Analysis
Principal Investigator: Trevor Paris, M.D. (904) 858-7602
Co-Prinicipal Investigator: Dorian Rose, Ph.D., PT, (352) 273-5278 or dkrose@phhp.ufl.edu
Enrollment Criteria: Participants must have had a CVA and a patient of Brooks Rehabilitation Hospital.
#139-2007: Neuro-Cognitive Subtypes of Traumatic Brain Injury: Revelance to Cognitive Rehabilitation
Purpose: To identify clinically-meaningful neuro-cognitive subtypes of severe traumatic brain injury survivors using functional magnetic resonance imaging (fMRI) and to determine their differential responsiveness to cognitive rehabilitation using a brief trial of goal management.
Study phase: Active enrollment through June 2009
Prinicipal Investigator: William M. Perlstein, Ph.D. (352) 273-6139 or (352) 294-0336 or wmp@phhp.ufl.edu
Enrollment Criteria: Participants must have severe TBI 1-2 years post injury and also 10 neurologically healthy adults.
#254-2006: Developing a Computer Adaptive Cognitive Measure in Traumatic Brain Injury
Purpose: To develop a computer adaptive way to measure cognitive skills during various phases of recovery in TBI.
Study phase: Data Analysis
Principal Investigator: Craig Velozo, Ph.D., (352) 273-6128 or cvelozo@phhp.ufl.edu
Enrollment Criteria: Participants in this study include patients with a traumatic brain injury, their clinicians, physicians and caregivers. Recruitment will be from the acute phase to 6 months post rehabilitation phase.
#2007-2002: Brain Injury Coping Skills (BICS)
Purpose: To gather pilot data examining the efficacy of a structured treatment group, called Brain Injury Coping Skills (BICS), designed for individuals with acquired brain injury (ABI) and their caregivers.
Enrollment Phase: Active Enrollment
Co-Principal Investigator: Jeffrey Wertheimer, Ph.D., (904) 858-7296 or Jeffrey.Wertheimer@brookshealth.org
Enrollment Criteria: Participants must be between 18 and 60 years old and have experienced an Acquired Brain Injury (including TBI, intercerebral hemorrhage, encephalopathies and strokes). They must be a native English Speaker or non-native speaker with conversational proficiency in the English language and the caregiver must be willing to participate in the study.
#UFJ2007-176: Improving Behavior Management of an Acute Brain Injury Unit: Enhancing Interdisciplinary Training and Collaboration
Purpose: The purpose of this study is to improve the behavioral management of patients on an acute inpatient rehabilitation brain injury unit. The objective is to measure the impact of a unit-wide behavior management training program on the healthcare professionals’ utilization of physical and chemical restraints.
Enrollment Phase: Active data collection through December 2008
Principal Investigator: Dr. Cynthia Beaulieu, Ph.D., ABPP-Cn, (904) 858-7651 or Cynthia.Beaulieu@brookshealth.org
UF03-2008-108 TBI-PBE: Traumatic Brain Injury- Practice Based Evidence
Purpose: To identify patient characteristics, including co-morbidity and complications, which explain variation in outcomes for TBI pts in acute rehabilitation. Identify medical procedures and therapy interventions or combinations of procedures and interventions associated with better outcomes, while controlling for patient characteristic. It is also designed to determine whether specific impairment by specific therapy interactions are associated with better outcomes.
Enrollment Phase: Data collection tools under development; active data collection begins October 2008 and continues through May 2011
Co-Principal Investigator: Dr. Cynthia Beaulieu, Ph.D., ABPP-Cn, (904) 858-7651 or Cynthia.Beaulieu@brookshealth.org